Limited Coverage Drugs - Rituximab

Generic Name

rituximab

Strength

10 mg/mL

Form

solution for intravenous injection

Special Authority Criteria

Approval Period 

Rheumatoid Arthritis (RA)

INITIAL

For the treatment of severely active Rheumatoid Arthritis (RA) in combination with methotrexate in patients who:

  • have contraindication(s) to anti-TNF agents
    OR

  • have failed to respond to an adequate trial of at least 1 anti-TNF agent.

    AND

  • when prescribed by a rheumatologist.

2 courses:

Each course consists of 2 doses of 1000 mg, administered at 0 and 2 weeks.

The 2 courses must be administered a minimum of 24 weeks apart.

RENEWAL

For RA patients who:

  • show a minimum 20% American College of Rheumatology response (ACR 20 response) compared to pre-rituximab status.

2 courses, to be administered within 1 year.

Each course consists of 2 doses of 1000 mg, administered at 0 and 2 weeks.

The courses must be administered a minimum of 24 weeks apart.                                                                                              

Granulomatosis with Polyangiitis or Microscopic Polyangiitis

INITIAL

For the induction of remission in severely active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) in patients who:

  • have had a severe intolerance or contraindication to cyclophosphamide
    OR

  • who have failed an adequate trial of cyclophosphamide.

    AND

  • when prescribed by a rheumatologist, nephrologist or respirologist.

Up to 4 weeks

RENEWAL

For GPA and MPA patients who:

  • have documented beneficial response to the initial induction therapy

    AND

  • have a current demonstrated need for re-treatment.

Up to 4 weeks

Relapsing-Remitting Multiple Sclerosis

INITIAL

As first-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (MS) diagnosed according to the 2010 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist from a designated MS clinic, for patients who meet all of the following criteria:

  • The patient has had at least 2 MS attacks in the previous 2 years, where an attack is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 24 hours in the absence of fever, and preceded by stability for at least 1 month.

    AND

  • The patient is ambulatory with or without aid (EDSS of 6.5 or less). 

    AND

  • The patient is 18 years of age or older.

1 Year

Initial course: 2 doses of 1000 mg, administered at 0 and 2 weeks.

Maintenance course: 1000 mg administered 6 months after initial course.

RENEWAL

As monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS,  who have demonstrated that the therapeutic benefits outweigh any potential risks, as shown by relapse rate, EDSS, MRI scan, or overall clinical impression.

1 Year

1000 mg administered every 6 months. 

CHANGE OF THERAPY

As monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS who have experienced failure or intolerance to a previous disease modifying therapy.

1 Year

Practitioner Exemptions

  • None

Special Notes

  • The definition of ACR 20 response is a 20% reduction in tender joint count and swollen joint count, as well as a 20% improvement in at least 3 of the following: patient's assessment of pain, patient's global assessment, physician's global assessment, patient's assessment of disability, and acute phase reactant measures (i.e. ESR or CRP).
  • For the treatment of RA: a completed Health Assessment Questionnaire must be submitted with the Special Authority request.
  • For the treatment of GPA and MPA: a completed Birmingham Vasculitis Activity Score (BVAS) is required as part of the application process (www.canvasc.ca/pdf/BVAS3fullonly.pdf). This and other BVAS forms will be accepted as long as there is a clear distinction between new/worse symptoms and persistent disease activity.

Special Authority Request Form(s)